Comparison Study of Psoriasis Severity Assessment Tools

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Drug: Cyclosporine A; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT02655705

oPASI1403

Details and patient eligibility

About

This study evaluates the performance of objective psoriasis severity assessment tool compared with a subjective assessment tool for the assessment of the improvement of psoriasis after oral cyclosporine A or methotrexate treatment.

Full description

Patients with moderate-to-severe psoriasis were randomly assigned to treatment for 16 weeks with either cyclosporine A (20 patients; male 200 mg/day, female 150 mg/day) or methotrexate (20 patients; initial dose with 10 mg/week, increased up to 15 mg/week). The primary outcome was to compare the difference between the conventional subjective Psoriasis Area and Severity Index (PASI) and the objective PASI by using Colorimeter at 2, 4, 8, 12, and 16 weeks of treatment. The secondary outcome was differences between cyclosporine and methotrexate for treatment of psoriasis, evaluating clinical efficacy and side effects.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Present with chronic plaque psoriasis based on a clinical diagnosis
• Have > 5% body surface area involvement at screening
• Are a candidate for systemic therapy
• Are male or female patients 18 years or older
• Have given written informed consent approved by the Institutional Review Board

Exclusion criteria

• Have predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
• Have had any of the systemic non-biologic psoriasis therapy (including neotigason, cyclosporine, and methotrexate) within 4 weeks prior to baseline
• Have had etanercept within 4 weeks prior to baseline
• Have had adalimumab and infliximab within 8 weeks prior to baseline
• Have had ustekinumab within 16 weeks prior to baseline
• Presence of significant hepatic or renal disorders
• Have uncontrolled arterial hypertension
• Are women who are lactating, breastfeeding or planning pregnancy
• Have any other condition that precludes from following and completing the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Cyclosporine A

Active Comparator group

Description:

Cyclosporine 200 mg/day (male) and 150 mg/day (female) orally, divided twice daily for 16 weeks

Treatment:

Drug: Cyclosporine A

Methotrexate

Active Comparator group

Description:

Methotrexate was started with 10 mg/week orally as a single dose, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose

Treatment:

Drug: Methotrexate